U.S. government plan for H5N1 scientific reviews irks scientists

A draft plan by the U.S. government to subject some H5N1 avian influenza virus grant requests to special reviews and secrecy is receiving mixed reviews from scientists.

"A Proposed Framework for Guiding the Department of Health and Human Services Funding Decisions about Highly Pathogenic Avian Influenza H5N1 Gain-of-Function Research" was the subject of discussion on Tuesday during a meeting of the National Science Advisory Board for Biosecurity. The document provides seven criteria studies would have to meet to be eligible for HHS funding, Science reports.

The one criterion generating the most controversy is the need to generate evidence that a studied virus could not be produced through natural evolutionary process in the foreseeable future.

"I'll just say out front (that it) has been very controversial within the U.S. government discussions," Amy Patterson, the associate director for science policy at the National Institutes of Health, said, according to Science. "I've heard questions like: 'What constitutes evidence? What's the foreseeable future?'"

Multiple members of the NSABB expressed concern about the requirement for evidence, saying that it would be difficult to obtain and the requirement might restrict many studies from receiving necessary funding.

"My read of this is that it really would put a stop ... to most of this research," Samuel Stanley, the new chair of the NSABB, said, according to Science. "I'm not sure how one would get that evidence...I think it sets a bar that may be too high in my opinion to allow you to do any gain-of-function (experiments) ... While I certainly appreciate the risks...they are very powerful tools when used appropriately."

Other criteria in the proposed document includes that the study must address scientific questions with high public health significance, that there are no feasible alternative methods to address the same question with less risk, the mitigation and management of biosafety and biosecurity risks, the broad sharing of the research to realize potential benefits to global health and using funding mechanisms to facilitate appropriate oversight of the research.

"I believe the NSABB is misguided in making gain-of-function experiments using H5N1 influenza viruses such an issue," Peter Palese, a virologist from Mount Sinai Hospital in New York City, said, according to Science. "Gain-of-function experiments are almost always loss-of-function experiments for another property. For example, making H5N1 influenza viruses more transmissible in ferrets (gain-of-function) results in a loss of pathogenicity of these (viral) mutants in the ferret (loss-of-function). Thus, the NSABB looks only at one side of the coin!"

Patterson said that the meeting was simply a first step to imposing broader rules on other fields of research.

"Scientists themselves can feel comfortable that the government is not going to be big brother and be asking them not to do this type of research," Kristine Beardsley, a bioterrorism expert on the White House's national security staff, said, according to Science.

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